Associate Director of Clinical Operations
MAPS PBCAnywhere - Remote Position13 days ago
About MAPS Public Benefit Corporation (MAPS PBC):
MAPS Public Benefit Corporation (MAPS PBC) catalyzes healing and well-being through psychedelic drug development, therapist training programs, and sales of prescription psychedelics prioritizing public benefit above profit. Founded in 2014, MAPS PBC is a wholly-owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS) a 501(c)(3) nonprofit. More information about the organization is available at http://www.mapsbcorp.com/
MAPS PBC is committed to the evolution of psychedelic healing modalities. We are building a diverse and inclusive workplace where we learn from each other. We value transparency, autonomy, experimentation, and kind, direct feedback. We welcome applicants who thrive in the midst of a growing organization that values science and healing.
We believe in diversity and inclusion of people of all backgrounds, genders, races, ethnicities, sexual orientations, educational backgrounds, military and veteran status, religions, abilities, and perspectives. MAPS PBC values and seeks applicants who are people of color, queer, transgender, gender non-conforming, and gender fluid people. MAPS PBC strives to establish a supportive, equitable and accessible work environment.
Associate Director (AD) provides operational leadership, management and guidance for success across Clinical Operations. The AD leads Clinical Operations for their functional activities associated with the execution of a clinical studies within their assigned programs and is responsible for management and oversight of all program-specific activities. The AD must be dynamic, creative and enjoy working within a growing and changing entrepreneurial environment that is mission-driven, results-driven and research-oriented. The AD will ensure that clinical trials are conducted in a timely manner in accordance with Standard Operating Procedures (SOPs), the principles of ICH/Good Clinical Practice and all applicable regulations governing the conduct of clinical trials. The AD has the responsibility to oversee teams that will protect the rights and well-being of human subjects and that the reported trial data are accurate, complete, and verifiable. The ideal individual will have the ability to exercise good judgment in a variety of situations, with strong written and verbal communication, organizational and team-building skills, and the ability to maintain a realistic balance among multiple priorities. The AD must be able to work under pressure at times to handle a wide variety of activities. The focus of the AD role is to oversee multiple clinical programs, protocols, and the teams responsible for those studies, working in close collaboration with program managers to meet team goals.
This is a remote position from a suitable home office with a private and quiet area to work. Secure internet and reliable phone reception are required. This position requires frequent phone and internet meetings. Certain home office expenses may be reimbursed. A work computer will be provided. Priority is placed on applicants based in the pacific time zone. Travel will be required.
Full time, exempt, salaried position. Must be available during normal business hours for a California-based company. Occasional night and weekend hours may be required.
- University Degree, minimum of 12 years of Clinical Research experience in the CRO/Pharmaceutical industry managing multiple teams or programs and having excellent knowledge in developing work organization models. Strong track record in leading clinical trial operations and teams under GCP/ICH Guidelines among other applicable regulatory agencies.
- Experience with regulatory activities in US and EU, as well as direct experience with FDA readiness
- Experience in international trial conduct and management, a plus.
- Fluent in English and local language(s).
- Proficiency in Microsoft Office (e.g. Word, Excel, Outlook)
- Ability to lead teams as well as, ability to work independently and within a team
- Transparent, open and clear communicator with written and verbal communication skills
- Self-motivating, able to prioritize and take initiative
- Ability to learn from leadership and provide sound judgement and decisions to teams aligned with leadership’s example and guidance
- Able to receive and give feedback, take and give direction
- Make informed decisions based on guidance from leadership and take 100% responsibility for actions
- Possess sound judgment, organizational skills, discretion with attention to detail and timelines
- Able to lead, motivate and understand the needs of others
- Strategic thinker and creative problem-solver capable of identifying risks and risk mitigation strategies
- Courage to be an “out-of-the-box” thinker, to take on calculated risks, and champion new ideas and approaches
- Strong teambuilding skills
- Able to work and manage quickly, effectively and efficiently in a remote virtual setting
- Coordination and planning of tasks while recognizing potential obstacles within set timelines
- Conscientious and precise delivery of work even when under pressure
- Be proactive in solution focused thinking, possessing a growth mindset
- Ability to make public presentations and represent MAPS/MPBC at conferences, when requested
- Computer skills with ability to use the following tools with some training (previous experience a plus): Microsoft Office (Word, Excel, Powerpoint, Outlook, Sharepoint), Smartsheet, Zoom and Asana
General AD Responsibilities:
ADs guide program managers, CTLs, CRAs and CSAs, contribute to clinical documents, oversee timelines, oversee, review invoicing and budgeting, ensure a plan for clinical supplies, contribute to clinical operation documents (e.g. SOPS, work instructions) and provide input to the leadership for strategic planning for successful department growth.
Cross- functional Representation:
Taking guidance from leadership, the AD will provide expertise, sound decision making and guidance (both strategic and operational), ensuring alignment with MPBC goals at the team level while managing high performing talent resulting in effective clinical teams.
Facilitate timely and effective communications of MPBC Leadership decisions and progress, as well as communicating significant decisions and issues (including those of any functional area sub-teams or committees) back to both MPBC Leadership and clinical teams.
Contribute to the establishment of clinical development timelines and goals that are aligned with company and that clinical sites and other functional teams are executing to optimally achieve those goals.
Program Planning & Management:
- Assists in implementing departmental strategy and mission, aligning with company initiatives
- Provides strategic input, oversight and expertise on clinical operations matters (i.e. feasibility, protocol design, study management, patient recruitment, study execution timelines, personnel & site management, and risk mitigation) collaborating with leadership to ensure all clinical trials are being conducted according to overall company wide strategic directives according to global quality initiatives (including adherence to participant safety, SOPs, ICH/GCP, FDA and other health authorities requirements)
- Ensure study timelines are up to date in coordination with Project Management and study leads, escalating issues/obstacles of strategic importance and study quality to the MPBC Leadership team for review, discussion and mitigation planning
- Provide key study and program metrics to executives and cross- functional stakeholders
- Compile and coordinate provision of resources required in support of all clinical trials for review and implemententaion with leadership
- Escalation point for any clinical operations issues that have a significant impact on overall study or program timelines, other functions, budget or quality, informing leadership as appropriate
- Oversees the development of cross-functional efforts to review process and project outcomes, by leading cross functional team initiatives for cross training, lessons learned and implementing continuous improvement projects informing leadership of risks and mitigations as appropriate
- Contribute to quality initiatives and provide input to clinical systems coordinating with the Systems and Quality Manager, including assiting with audit planning and inspection readiness initiatives
- Ensure clinical teams are functioning under program lead management, providing oversight, guidance and mentorship as appropriate in collaboration with leadership
- Participate in relationship management, both inside and outside the organization, manages research contracts in coordination with leadership and program lead managers, in order to provide priority guidance and value-add to the department and the company at large
- Contributes to and implements beneficial training and planning to scale the clinical operations teams effectively
- Ensure timeliness and provides guidance to program leads managers, CTLs and clinical teams, holding them accountable for achieving assigned deliverables within timelines & budget, in accordance with quality standards, ensuring use of appropriate management systems
- In coordination with leadership and program leads ensure site and internal budgets are aligned with Finance and Contracts budget models, including proper staff allocation
- Ensure site payments and invoices are processed in a timely manner in alignment with budgets, providing oversight to program leads
- Implement and assist in building teams as needed to address the needs of external partnerships, new study protocols, collaborations and opportunities in conjunction with leadership, passing ready projects onto the appropriate program lead managers and clinical operations teams
- Ensure proper snapshot and project management outputs for leadership in the form of dashboards, presentations and updates for board meetings as well as speaking engagements, as appropriate
- Provide input to leadership to ensure strategic planning resourcing
- In collaboration with program leads and Project Management reviews and confirms risk identification and mitigation planning is in place for each clinical site as well as for the overall programs
- Ensure timely and effective communication among the leadership, Clinical Operations, clinical sites, and cross functional departments as appropriate
- Ensure information from project management and tracking systems are up to date with current clinical operations timelines
- Contribute to and review protocol and protocol related documents, ensuring proper timelines are kept
- Ensure rater groups are staffed and prepared for study start providing oversight for the Independent Rater Pool, as assigned
- Ensure timely and proper IRB submissions in collaboration with program leads
- Maintain timely and effective communication facilitating the exchange of information cross-functionally as appropriate
- In collaboration with program leads, be a point of escalation for clinical trial oversight assessing trends in monitoring findings with clinical teams, Safety and Quality, as appropriate (deviations/data listings/communications) ensuring monitoring is performed according to the data safety monitoring plan, GCP and SOPs
- Ensure monitoring trip reports are reviewed in collaboration with program leads according to timelines, SOPs and plans, and make any necessary recommendations for contingency planning
- In collaboration with program leads, ensure set up of study centers, which includes ensuring each center has the trial materials and training on trial-specific industry standards
- Ensure with program leads and CTLs verification of data, plan data audits, data review and oversee database lock activities according to agreed upon timelines
- Ensure Clinical Operation input into systems (i.e. CTMS) implementation
- Ensure Clinical Operations input into SOPs, WI, Policies and Plans, as appropriate
- Identifies and proposes process and system improvements to maintain quality and effective deliverables
- Implements process and system improvements to maintain quality and effective deliverables under direction of leadership
- Oversee training plan implementation, mentor program leads and CTLs , including strategic cross functional training and improvement initiatives for the Clinical Operations group
- Collates feedback from clinical teams identifying competencies for leadership review providing assessments of skills required, selecting and recruiting staff, defining appraisal, skills, and pathways in order to plan and review career progression and assess training requirements in collaboration with senior leadership
- Supports the leadership in analyzing performance, identifying root causes of non/poor performance and implementing corrective actions, periodically assessing the performance of clinical operations staff based on feedback from Directors and other relevant roles
- Reviews factors related to evaluation, development, and retention of the clinical research operations staff, establishing performance goals by role
- In collaboration with leadership, plans and monitors the workload of clinical operations staff (Employees, In-sourced and Contractors)
- Builds the team by proper communication and motivation leading by example, committing to the use of The Conscious Leadership Group (CLG) principles in day to day interactions and enforcing company values and mission
- Assess and review team communication plans and meeting schedules to support effective and beneficial communication
- Informs leadership of issues that can jeopardize business relationships with the Sponsor
- Monitors and enforces compliance with systems, processes and policies and all applicable regulations
Exempt, salaried position, not eligible for overtime.
Salaried compensation commensurate with experience. Full benefits package included.